IRIS INDUSTRY MANAGER ROLE AND LETTER of INTENT

I hereby write to you to have general information regarding the new IRIS platform and the Scientific Advice Procedure. In particular, my focus is on the Scientific Advice procedure.

I read on the guide for applicants that for obtaining an IRIS account, you should have:

• an active EMA account
• the Organisation that is registered in EMA’s Organisation Management Service (OMS).
• a valid EMA customer account number
• a valid Research Product Identifier (RPI)
• the appropriate user access role and affiliation to an Organisation

Question 1:

Regarding the latter requisite, I would kindly like to ask you if, for instance, companies that want to submit a scientific advice, could nominate someone from an external consulting company on their behalf as the IRIS industry manager?

Question 2:

The application form via IRIS will replace the former Letter of Intent, or the LOI has to be attached with the Briefing document during the submission of the SA request via IRIS?

Thank you in advance for your time and cooperation. I look forward to hearing from you.

1. Yes, an EMA user can request affiliation to any organisation, and have more than one affiliation.
2. Yes, the application forms replaces the letter of intent. You will still need to upload the scientific document (briefing document).